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Regulatory Links

USA   Food and Drug Association (FDA)
http://www.fda.gov
Europe   European Union Drug Regulatory Agency (Eudra)
http://dg3.eudra.org
    EMEA
http://www.emea.eu.int
    Heads of Agencies for the European Union
http://heads.medagencies.org
UK   Medicines and Healthcare products Regulatory Agency (MHRA)
http://www.mhra.gov.uk
Germany   BfArM
http://heads.medagencies.org/germany.html
Portugal   Instituto Nacional da Farmácia e do Medicamento
http://www.infarmed.pt/index2.html
France   French Health Products Safety Agency
http://agmed.sante.gouv.fr
Spain   Agencia Española del Medicamento
http://www.msc.es/agemed
Belgium   http://www.afigp.fgov.be
Norway   Norway Medicines Board
http://www.legemiddelverket.no
Sweden   Medical Products Agency
http://www.mpa.se/eng/index.shtml
Finland   National Agency for Medicines
http://www.nam.fi/english/index.html
Italy   Ministero della Salute
http://www.ministerosalute.it/medicinali
Netherlands   CBG
http://www.cbg-meb.nl
Australia   Therapeutic Goods Administration (TGA)
http://www.tga.gov.au
Bulgaria   Bulgarian Drug Agency
http://www.bda.bg/web_engl/main.htm
Canada   Therapeutic Products Directorate (TPD)
http://www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng
Chile   Chile Regulatory Agency
http://www.minsal.cl
Russia   Czech Republic
http://www.sukl.cz/enindex.htm
Denmark   The Danish Medicines Agency
http://www.laegemiddelstyrelsen.dk/index_en.htm
Estonia   State Agency of Medicines
http://www.sam.ee
Greece   EOD
http://www.eof.gr
Hong Kong   Hong Kong Department of Health Welfare and Food
http://www.fwfb.gov.hk/eindex.html
India   Ministry of health and family welfare
http://mohfw.nic.in
Ireland   Irish Medicine Board
http://www.imb.ie
Japan   Ministry of Health, Labour and Welfare (MHLW)
http://www.mhlw.go.jp/english
Russia   Ministry of Health of the Russian Federation
http://www.minsalud.gov.com
Switzerland   Swiss Medic
http://www.swissmedic.ch

FDA

FDA Home Page
www.fda.gov/

FDA Freedom of Information Index
www.fda.gov/foi/electrr.htm

FDA Warning Letters
www.fda.gov/foi/warning.htm

FDA Recalls
www.fda.gov/opacom/Enforce.html

FDA Inspection Guides
http://www.fda.gov/ora/inspect.ref/iglist.html

FDA Compliance References
http://www.fda.gov/ora/compliance.ref/default.htm

CFR Titles
www.access.gpo.gov/nara/cfr/cfr-table-search.html

U.S. Code
www.uscode.house.gov/usc.htm

CBER Guidelines
http://www.fda.gov/cher/guidelines.htm

CDER Guidelines
www.fda.gov/cder/guidance/index.htm

CDRH Guidelines
www.fda.gov/cdrh/ggpmain.html

CDRH Documents
www.fda.gov/cdrh/topindx.html

CGMP
www.fda.gov/cder/dmpq/index.html

Investigation Operations Manual
www.fda.gov/ora/inspect_ref/iom/iomtc.html

FDA Medwatch (Medical Product Reporting Program)
www.fda.gov/medwatch/

FDA Phone Book (Staff Directory & Search Program for Employees of HHS-includes email addresses)
directory.psc.gov/employee.htm


International Standards Organization

International Standards Organization
www.iso.org


Medical Industry Associations

Parenteral Drug Association (PDA)
http://www.pda.org/

Institute of Validation Technology (IVT)
http://www.ivthome.com/

American Society of Quality (ASQ)
http://www.asq.org/

Intl. Society for Pharmaceutical Engineers (ISPE)
http://www.ispe.org/

Pharmaceutical Research & Manufacturers of America (PHRMA)
http://www.phrma.org/

Regulatory Affairs Professionals (RAPS)
http://www.raps.org/

Drug Information Association (DIA)
diahome.org

American Association of Pharmaceutical Scientists (AAPS)
http://www.aaps.org/

Food & Drug Law Institute (FDLI)
http://www.fdli.org/

Biotechnology Industry Association
http://www.bio.org/

Medical Device Manufacturers Association (MDMA)
http://www.medicaldevices.org/

Health Industry Manufacturers Association (HIMA)
http://www.himanet.com/


Industry Publications & Publishers

MedMarket
http://www.medmarket.com/

Advanstar  (Pharmaceutical Executive & Pharmaceutical Technology Magazines)
http://www.advanstar.com/

Biopharm Magazine
http://www.biopharm-mag.com/

F-D-C Reports (Green, Pink, Gold etc. Sheets)
http://www.fdcreports.com/

Washington Information Source Company (Warning Letter Bulletin)
http://www.fdainfo.com/

Medical Device Link (MDDI magazine)
http://www.devicelink.com/

The Member States - EU

 Protocol Order of EU Member State Flags 

#

Flags

English

French

Country

1

Belgium

Belgique

België - Belgique

2

Czech Republic

République Tchèque

Česká Republika